Kornimate/medical-research-clean huggingface dataset:
immune registry for organ transplantation from covid positive donors.

Conditions: COVID-19; Organ Transplant

Summary: the purpose of this study is to collect data generated by standard clinical practice to determine the short term and long term clinical outcomes of recipients of solid organ transplantation from covid-19 infected donors and compare it to recipients with organ transplant from covid-19 negative donors.

to advance science, it is helpful for researchers to share information. they do this by putting data or biospecimens into one or more scientific databases (called registries or repositories), where it is stored along with information from other studies. researchers can then study the information in other ways and combine information from many studies to learn even more. the researchers are asking for permission to store and share personal information in a research registry to help research studies in the future. the information will be available for any research question, such as research to understand what causes certain diseases in patients with solid organ transplant, development of new scientific methods, or the study of where different groups of people may have come from. information from participant's medical chart will be securely stored in the vcu database. this will include donor information (including covid test results, radiologic findings, symptoms, treatments, cause of death etc.) as well as recipient information (including demographics, labs, biopsy findings if any, length of hospital stay, covid transmission, graft function, immunosuppression, post-transplant complications and long term clinical outcomes like patient and graft survival, etc.). data will be collected during routine clinical care. the study will include the following tests: * pre transplant covid-19 pcr on the nasal swab (as standard transplant protocol), serum covid-19 specific t-cell immune response, and serum covid-19 spike antibody as a study protocol in all the recipients. * posttransplant covid-19 spike antibody in the serum around 4 weeks after the completion of induction thymoglobulin as a study protocol in all the recipients. * daily covid-19 pcr in serum from post-operative day 1 till post-operative day 4 as a study protocol in the recipients with organ transplant from covid-19 positive donors. * posttransplant covid-19 pcr nasal swab once around one-week post-transplant as study protocol in the recipients with organ transplant from covid-19 positive donors. * covid-19 t-cell specific immune response will be checked in the recipient's serum at 4 weeks post-transplant as study protocol in all the recipients. * according to the standard transplant protocol post-transplant donor-specific antibodies will be checked around 2 weeks post transplant and the results will direct the donor-derived cell-free dna testing in all the recipients.

Eligibility criteria:
inclusion criteria: - adult (\>18 years old) male and female solid organ transplant recipients exclusion criteria: * absence of informed consent for the clinical protocol and the registry. * prisoners will be excluded from the study.
comparing non-fixation of mesh to mesh fixation in laparoscopic inguinal hernia repair

Conditions: Inguinal Hernia

Summary: the purpose of the study is 1. to compare the recurrence rate of the laparoscopic total extra peritoneal inguinal hernia repair without fixation of the mesh to mesh fixation under spinal anesthesia 2. to test whether non-fixation of mesh leads to less pain compared to the repair when the mesh is fixed.

hernia repair is one of the most common surgery performed all over the world. the same is true about india. with more than a billion population, the number of hernia patients in india perhaps run in millions. the laparoscopic repair is increasingly becoming popular in india. decreased post operative pain and lesser morbidity are the main advantages of total extra peritoneal repair (tep) over open hernia repair. laparoscopic hernia repair is now recommended as the method of choice for bilateral and recurrent inguinal hernias. the disadvantages of tep are requirement of general anesthesia (ga), need to fix the mesh, seroma formation and difficult learning curve. fixation of mesh with metal staples, apart from increasing the cost, may lead to new post operative groin pain which even becomes chronic in small percentage of patients. this had led to various studies showing that the non-fixation of mesh is safe, cost effective and lead to no increased risk of hernia recurrence compared to the conventional open hernia repair. requirement of ga for tep repair also had several disadvantages compared to regional anesthesia such as significant hemodynamic changes, delayed recovery, post operative nausea and vomiting, increased cost and inability to give anesthesia in high cardio-pulmonary risk patients. several studies in recent past have demonstrated tep is feasible and safe in regional anesthesia (epidural or spinal) as well. we earlier reported that tep repair could be done without fixation of the mesh under regional anesthesia. this study is a randomized controlled trial (rct) comparing the outcome of non-fixation of mesh during laparoscopic inguinal hernia repair with fixation of mesh under spinal anesthesia. the end points measured would be the recurrence of the hernia and pain in the post operative period.

Eligibility criteria:
inclusion criteria: * all reducible inguinal hernias will be included in the study exclusion criteria: * irreducible hernia after anesthesia * obstructed and strangulated hernias * pediatric hernias * associated other hernias like ventral hernias * unfit for spinal anesthesia

Keywords: hernia, laparoscopic, recurrence, pain, inguinal
radioembolization trial utilizing eye90 microspheres™ for the treatment of hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma; Hepatocellular Carcinoma Non-resectable; Liver Cancer

Summary: this is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of eye90 microspheres® in the treatment of subjects with unresectable hepatocellular carcinoma (hcc). eye90 microspheres is a medical device containing yttrium-90 (y-90), a radioactive material, and provides local radiation brachytherapy for the treatment of liver tumors.


Eligibility criteria:
inclusion criteria: * must have a confirmed diagnosis of hcc by imaging confirmation with liver imaging reporting and data system (lirads) category 5 or confirmation of hcc via biopsy. * no extra hepatic disease. * up to 3 lesions with at least one lesion ≥ 2 cm in diameter (long axis) measurable by computed tomography (ct), cbct, or mri. at least one lesion must be identified as a target lesion as defined by mrecist. * maximal single lesion size of ≤ 8 cm and sum of the maximal tumor dimensions of ≤ 12 cm with the entire tumor burden expected to be treatable within the perfused volume. * intent to treat all lesions within a single session. * hypervascular on cbct, ct, or mri. * evidence that \> 33% of the total liver volume is disease-free and will be spared eye90 treatment. * life expectancy of ≥ 6 months. * ≥ 18 years old at the time of informed consent exclusion criteria: * platelet count \ 50% normal. * hemoglobin ≤ 8.5 g/dl (subjects that are non-responders to transfusion or medical management must be excluded). * inr \> 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic procedures). * alt \> 5x upper limit. * ast \> 5x upper limit. * bilirubin ≥ 2.0 mg/dl. * egfr ≤ 50 ml/min/bsa. * macrovascular invasion. * incompetent biliary duct system, prior biliary intervention, or a compromised ampulla of vater. * estimated lung dose \> 30 gy as calculated using the lung shunt fraction and partition model.

Keywords: hepatocellular carcinoma liver cancer liver diseases internal radiation brachytherapy radioembolization y90 yttrium-90 eye90 microspheres
preoxygenation with high-flow nasal oxygen in adult trauma patients during rapid sequence induction anaesthesia

Conditions: Anesthesia; Hypoxia; Trauma; Rapid Sequence Induction

Summary: previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes. it has recently been demonstrated, in several studies, that high flow nasal oxygen (hfno) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. the mean apnea time among the patients in the previous studies have been relatively short. patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract. based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (rsi) technique. the trial is set to be a before-and-after study. during approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. during the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. data will be registered and compared to the data collected from the patients preoxygenated with facemark. the general purpose of this project is to compare the preoxygenation technique based on hfno with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (rsi) intubation in trauma patients in need of immediate anaesthesia.


Eligibility criteria:
inclusion criteria: * 1 adult, ≥18 years old * 2 level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre). exclusion criteria: * 1 patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.
severe pandemic h1n1 infection in icu: comparative resource utilization

Conditions: Novel H1N1 Influenzal Acute Respiratory Infection

Summary: the main purpose of this study is to review the resource utilization of severe adult h1n1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ecmo, hfo) in critically ill patients in winnipeg. secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ards). the investigators will also look at the percentage of patients that required icu care as compared to those who could be cared for on medical wards. the investigators will determine the resources used by both groups and compare. finally the investigators will record the frequency of chronic comorbidities in hospitalized adult h1n1 patients.


Eligibility criteria:
inclusion criteria: 1. \> 18years, 2. suspected or confirmed influenza (appendix a) 3. requirement for icu admission due to respiratory distress or critical illness defined as one of:a) inspired oxygen need of \>50% for at least 4 hours (for fio2 for non-intubated patients see appendix b) b) mechanical ventilation c) patient is receiving inotrope or vasopressor exclusion criteria: 1. age less than 18 years
drowning in denmark: a registry-based study of fatal and non-fatal drowning from 2016 to 2023

Conditions: Drowning

Summary: using nationwide data from the prehospital electronic health records from 2016 to 2023, this registry-based cohort study aims to establish a nationwide epidemiological profile of non-fatal and fatal drowning patients in denmark in adherence with the utstein style for drowning (usfd) recommended guidelines for uniform reporting of data from drowning. this includes reporting the annual incidence rates per 100,000 person-years, assessing the associations between predefined prognostic variables and 30-day survival, and reporting the spatial distribution of drowning incidents presented on a map of denmark.

purpose the purpose of this study is to establish a nationwide epidemiological profile of non-fatal and fatal drowning patients in denmark which can be used to target educational, preventative, rescue, or treatment strategies to reduce the number of fatal and non-fatal drowning incidents in denmark. objectives the primary objective is to estimate the yearly incidence rates of drowning patients in denmark treated by the danish emergency medical services from 2016 to 2023. the secondary objective is to report the associations between predefined prognostic variables and 30-day survival. study design a nationwide registry-based study with data from the danish drowning cohort (extracted from the prehospital electronic health records using syndromic surveillance and extensive manual validation) from 2016 to 2023 with 30-day follow-up.

Eligibility criteria:
inclusion criteria: * the patient must have been experiencing respiratory impairment from submersion or immersion in liquid and * the patient must have been in contact with the danish prehospital emergency medical services. exclusion criteria: - patients were excluded if the incident involved submersion or immersion with aspiration, but the patient did not experience respiratory impairment. for example, if the patient was rescued from the water without signs of respiratory impairment, or if the respondent reported "a few coughs" or "voluntary cough".

Keywords: drowning non-fatal utstein register study retrospective reigstry-based study
the effects of parenteral ω-3 polyunsaturated fatty acid on postoperative complications of patients with crohn's disease

Conditions: Crohn Disease

Summary: this study is intended to investigate the safety and efficacy of ω-3 polyunsaturated fatty acid-based parenteral nutrition (pn) for patients with crohn's disease.


Eligibility criteria:
inclusion criteria: 1. diagnosis as crohn's disease according to definition; 2. bowel resection; 3. with parenteral nutrition at least 5 days 4. 18 years old\<age\<75 years old; 5. sign the informed consent. exclusion criteria: 1. emergency surgery; 2. with severe comorbidity and/or organ (kidney,liver,or heart) dysfunction; 3. incomplete laboratory data; 4. with parenteral nutrition before surgery; 5. pregnant; 6. allergy of ω-3 polyunsaturated fatty acid.

Keywords: postoperative complications
comparison of phase-variance optical coherence tomography and fluorescein angiography in retinovascular imaging

Conditions: Age-related Macular Degeneration; Diabetic Retinopathy; Hypertensive Retinopathy; Retinal Vein Occlusion; Retinal Artery Occlusion

Summary: the purpose of this study is to determine whether phase variance optical coherence tomography (pv-oct), a software-based optical coherence tomography(oct) image processing technology, can be used to generate angiographic images of the retinochoroidal vasculature that are comparable to those produced by fluorescein angiography (fa), the current gold standard diagnostic test.

fluorescein angiography (fa) has long been the gold standard for vascular imaging of the retina and choroid. it is a test that involves the intravenous injection of fluorescein dye, followed by imaging of the dye's passage through the blood vessels inside the eye. it is commonly used to diagnose many forms of retinovascular disease, as well as to assess the retina's response to various therapeutic interventions. while fa is a relatively safe diagnostic test, it carries the risk of both minor and major side effects. these include nausea and vomiting, yellowing of the skin and urine, vascular extravasation with skin eruption and necrosis, vasovagal reactions, myocardial infarction, respiratory failure, anaphylaxis, cardiopulmonary arrest, and death. additionally, the test is time-consuming, technically difficult to perform, and requires patients to undergo the discomfort associated with intravenous access. despite these drawbacks, fa is still commonly used in clinical practice, as there are no existing alternative tests with the ability to provide comparable detail of the retinal and choroidal vasculature. phase-variance optical coherence tomography is a novel, noninvasive, software-based technology capable of generating angiographic images from the data gathered by standard oct scans. preliminary research suggests it can produce high-definition representations of the retinal and choroidal vasculature which may be more detailed than the images produced by fa.

Eligibility criteria:
inclusion criteria: 1. patients with suspected or established retinovascular disease who are going to undergo fa as part of their usual clinical evaluation. 2. patients must be age 13 or above. 3. patients must be able to speak and understand the english language in order to provide informed consent. exclusion criteria: 1. any patients who are unwilling to participate or provide informed consent. 2. any patients who are pregnant at the time of enrollment. 3. any patients with ocular media opacities which prevent clear evaluation of the fundus by either fa or oct.

Keywords: retinovascular disease imaging fluorescein angiography fa angiography optical coherence tomography oct phase variance comparison age-related macular degeneration diabetic retinopathy hypertensive retinopathy retinal vein occlusion retinal artery occlusion
phase ii of efficacy and toxicity of maintenance sub. rituximab after induction in relapsed mcl and non-eligible hsct

Conditions: Mantle-cell Lymphoma

Summary: 1. primary endpoint: time to relapse/progression (ttp) after achieving a complete or partial response with the (r-gemoxd)-induction therapy 2. secondary endpoints: 1. quality of response obtained after subcutaneous rituximab maintenance. 2. progression-free survival (pfs) 3. overall survival (os) 4. time to next therapy (ttnt) 5. value of mrd in the disease outcome 6. toxicity

this is a phase ii trial evaluating the role of maintenance with subcutaneous rituximab in patients with stage ii-iv relapsed or refractory mantle-cell lymphoma with complete or partial response after the administration of a salvage regimen with r-gemox-d. before the study start and in order to standardize the results, the same r-gemox-d salvage regimen will be used: rituximab: 375 mg/m2 on day 1, gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), dexamethasone 20 mg on day 1-3. cycles should be repeated every 14 days, up to 8 cycles. patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy. patients will be evaluated every 2 months during treatment study phase and every 4 months in the follow up phase. more details in appendix 1 (schedule of assessments)

Eligibility criteria:
inclusion criteria: * basal diagnosis of mantle-cell lymphoma in relapse or refractory. * achievement of a cr or pr after salvage therapy with r-gemoxd (6 to 8 cycles) as previously described4-5. * age \> 18 years. * one or maximum two prior chemotherapy or immunochemotherapy lines. * patients should not be considered candidates for high-dose chemotherapy and autologous stem-cell transplantation. * no clinical evidence of cns involvement * signed informed consent * serum creatinine less than 2 and/or bilirrubin less than 2.5 unl. * pregnant or lactating woman. fcbp must agree to ongoing pregnancy testing during the course or study and commit to use effective contraception during the study exclusion criteria: * prior organ transplantation. * hiv positive. * hbv related disease * any serious active disease or co-morbid medical condition (according to the investigator's decision) * any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 cervix carcinoma. * less than 50% of tumor response. * platelet counts less than 50 x 109/l. * neutrophil counts less than 1.0 x 109/l.

Keywords: relapsed or refractory patients with mantle-cell lymphoma progression after high-dose chemotherapy and autologous hpt
improvement of pain following robotic sacrocolpopexy and rectocele repair for pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: to determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.

in the last 20 years, laparoscopic surgery has assumed an important role in gynecological surgery. unfortunately, patient surveys indicate there has been little improvement in the incidence and severity of postsurgical pain in the past two decades. postoperative pain is a common complaint, occurring in 5-15% of patients and has been shown to significantly contribute to overall patient dissatisfaction. it can lead to increased consumption of opioids, with subsequent nausea, delayed bowel function, and prolonged postoperative recovery. in an attempt to address pain related complications with port-site wounds, various methods of pain control have been attempted. currently, no standard of care exists and management is based on surgeon and anesthesiologist preferences. this study seeks to determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.

Eligibility criteria:
inclusion criteria: * adults 18 years of age or older * planning for surgical treatment of pop with robotic sacrocolpopexy and rectocele repair under general anesthesia * patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included exclusion criteria: * pregnant or nursing * allergy to bupivacaine * history of drug/alcohol abuse * severe cardiovascular, hepatic, renal disease, or neurological impairment * long-acting opioid use within 3 days or any opioid use within 24 hours before surgery * contraindication to: acetaminophen, oxycodone, non-steroidal anti- inflammatory drugs (nsaid) * administration of an investigational drug within 30 days before study * chronic pain syndromes * daily nsaid/opioid use * patients not undergoing general anesthesia * patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or fistula repair

Keywords: sacrocolpopexy rectocele repair